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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINI MOTOR DRIVE UNIT, EP-1, SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MINI MOTOR DRIVE UNIT, EP-1, SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205357
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2017
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. A visual inspection was performed on the product and no issue was observed. There was a relationship found between the returned device and the reported incident. Mdu failed for motor stall error and overheating. Cause of motor stall and overheating is a jammed motor/gearbox. The motor/gearbox assembly could not be removed from the housing for further assessment because this type of mdu has the motor/gearbox potted inside of housing. The complaint was confirmed and the root cause has been determined to be a jammed motor/gearbox assembly. Factors which can contribute to jammed motor/gearbox include cleaning and sterilization methods and the chemicals involved. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
Event Description
It was reported that the hand piece of the mini motor did not work during the surgery. The pedal was activated and the console looked as if it was working but the blade did not move, the pedal was changed, the blade was changed, but it did not work. After trying several times and disconnecting and reconnecting the console, it started to whistle and an engine error sign came out. Doctor then decided to perform an open surgery to complete the procedure. No patient injuries were reported.
 
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Brand NameMINI MOTOR DRIVE UNIT, EP-1,
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w. william cannon drive
austin, TX 78735
MDR Report Key6976526
MDR Text Key139550086
Report Number1643264-2017-01025
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205357
Device Catalogue Number7205357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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